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Ustekinumab Does Not Increase Risk of Adverse Events: A Meta-Analysis of Randomized Controlled Trials
Rolston, Vineet S; Kimmel, Jessica; Popov, Violeta; Bosworth, Brian P; Hudesman, David; Malter, Lisa B; Hong, Simon; Chang, Shannon
GOALS AND BACKGROUND/OBJECTIVE:Ustekinumab (UST) is a monoclonal antibody inhibitor of IL-12/IL-23 approved for the treatment of Crohn's disease (CD) and ulcerative colitis (UC). We conducted a meta-analysis to compare rates of adverse events (AEs) in randomized controlled trials (RCTs) of UST for all indications. STUDY/METHODS:A systematic search was performed of MEDLINE, Embase, and PubMed databases through November 2019. Study inclusion included RCTs comparing UST to placebo or other biologics in patients aged 18Â years or older with a diagnosis of an autoimmune condition. RESULTS:Thirty RCTs with 16,068 patients were included in our analysis. Nine thousand six hundred and twenty-six subjects were included in the UST vs placebo analysis. There was no significant difference in serious or mild/moderate AEs between UST and placebo with an OR of 0.83 (95% CI 0.66, 1.05) and 1.08 (95% CI 0.99, 1.18), respectively, over a median follow-up time of 16Â weeks. In a sub-analysis of CD and UC trials, no difference in serious or mild/moderate AEs in UST versus placebo was seen. CONCLUSIONS:UST was not associated with an increase in short-term risk of AEs.
PMID: 32445049
ISSN: 1573-2568
CID: 4447192
Increased Sessile Serrated Adenoma Detection Rate With Mechanical New Technology Devices: A Systematic Review and Meta-Analysis
Verheyen, Elijah; Castaneda, Daniel; Gross, Seth A; Popov, Violeta
GOAL/OBJECTIVE:This meta-analysis aims to compare the sessile-serrated adenoma detection rate (SSADR) of currently available mechanical new technology devices (NTDs) to conventional colonoscopy (CC). BACKGROUND:NTDs including Endocuff, EndoRing, G-Eye, and AmplifEYE were developed with the aim of improving adenoma detection rate by enhancing colonic mucosal visualization. Increasing awareness of the risk of sessile-serrated adenoma progression to malignancy has ushered a need to increase the detection of these characteristically flat lesions. STUDY/METHODS:Embase and PubMed/Medline databases were searched from inception through January 2019 for published manuscripts or major conference abstracts reporting SSADR with Endocuff, EndoRing, G-Eye, AmplifEYE, and CC. Randomized controlled trials, high-quality case-control, cohort, and observational studies in adults with >10 subjects were included. The primary outcome was pooled SSADR odds ratio (ORs) with 95% confidence interval (95% CI) comparing CC with the NTDs. In addition, an analysis comparing each device to CC was performed. RESULTS:Of 207 citations identified, a total of 14 studies with 12,655 subjects were included in our analysis (5931 subjects with NTDs and 6724 with CC). There were 12 studies with Endocuff, 2 with EndoRing, 1 with G-EYE, and 1 with AmplifEYE. The mean age was 62.4 years and 57.5% were males. Pooled SSADR with NTDs was 12.3% as compared with 6.4% with CC, with an OR of 1.81 (95% CI: 1.6-2.0, I2: 77%). Analysis of Endocuff alone yielded an OR 1.81 (95% CI: 1.6-2.1, I2: 79%). CONCLUSION/CONCLUSIONS:Mechanical NTDs, notably Endocuff, are a safe and effective tool to increase the SSADR.
PMID: 32649444
ISSN: 1539-2031
CID: 4825592
The impact of anthropometric parameters on colorectal cancer prognosis: A systematic review and meta-analysis
Jaspan, Vita; Lin, Kevin; Popov, Violeta
BACKGROUND & AIMS/OBJECTIVE:Our study aims to clarify the relationship between weight parameters and colorectal cancer outcomes. METHODS:statistic. RESULTS:Our meta-analysis included 45 studies encompassing 607,266 patients. Obesity was associated with increased odds of overall mortality and CRC-specific mortality compared to normal weight (p < 0.001). Patients with underweight BMI had increased odds of CRC-specific mortality compared to normal BMI but were not significantly different from obese BMI. CONCLUSIONS:Obese and underweight BMI are associated with increased CRC-specific and overall mortality compared to normal BMI. Long term prognosis was similar for patients with obese and underweight BMI.
PMID: 33497759
ISSN: 1879-0461
CID: 4807412
Gender disparities in advanced endoscopy fellowship
Yu, Jessica X; Berzin, Tyler M; Enestvedt, Brintha; Anderson, Michelle A; Popov, Violeta B; Thompson, Christopher C; Schulman, Allison R
Background and study aims  Women remain underrepresented in gastroenterology, especially advanced endoscopy. Women represent 30 % of general gastroenterology fellows; yet in 2019, only 12.8 % of fellows who matched into advanced endoscopy fellowship (AEF) programs were women. Methods  We administered a web-based survey to the program directors (PDs) of AEF programs that participated in the 2018-2019 American Society for Gastroenterology (ASGE) match. We assessed PD and program characteristics, in addition to perceived barriers and facilitators (scale 1-5, 5 = most important) influencing women pursuing AEF training. Results  We received 38 (59.3 %) responses from 64 PDs. 15.8 % (6/38) of AEF PDs and 13.2 % (5/38) of endoscopy chiefs were women. By program, women represented 14.8 % (mean) ± 17.0 % (SD) of AEF faculty and 12.0 % (mean) ± 11.1 % (SD) of AEF trainees over the past 10 years. 47.4 % (18/38) programs reported no female advanced endoscopy faculty and 31.6 % (12/38) of programs have never had a female fellow. Percentage of female fellows was strongly associated with percentage of female AEF faculty (ß = 0.43, P  < 0.001). Inflexible hours and call (mean rank 3.3 ± 1.1), exposure to fluoroscopy (2.9 ± 1.1), lack of women endoscopists at national conferences/courses (2.9 ± 1.1) and lack of female mentorship (2.9 ± 1.0) were cited as the most important barriers to recruitment. Conclusion  We utilized a survey of AEF PDs participating in the ASGE match to determine program characteristics and identify contributors to gender disparity. Women represent a minority of AEF PDs, endoscopy chiefs, advanced endoscopy faculty and AEF trainees. Our study highlights perceived barriers and facilitators to recruitment, and emphasizes the importance of having female representation in faculty, and leadership positions in endoscopy.
PMCID:7892265
PMID: 33655031
ISSN: 2364-3722
CID: 4801452
The Impact of Bariatric Surgery Compared to Metformin Therapy on Pregnancy Outcomes in Patients with Polycystic Ovarian Syndrome: a Systematic Review and Meta-analysis
Chang, Catherine; Chang, Steven; Poles, Jillian; Popov, Violeta
BACKGROUND:Polycystic ovarian syndrome (PCOS) is a leading cause of infertility among women of reproductive age. The interplay between hyperinsulinemia and obesity results in many of the reproductive and hormonal changes seen in PCOS including abnormal menses, infertility, and pregnancy loss. While bariatric surgery has been found to be an effective treatment strategy for morbid obesity, its role in the management of PCOS-related infertility compared to standard therapy (metformin) is less clear. AIMS/OBJECTIVE:To assess the impact of bariatric surgery on pregnancy outcomes in women with PCOS compared to metformin therapy in a systematic review and meta-analysis. METHODS:MEDLINE, EMBASE, PubMed, and Google Scholar were searched from inception to August 2019. Studies that reported quantitative data on pregnancy outcomes on women of reproductive age with PCOS with at least a 3-month follow-up and a minimum of 5 or more sample size were included. The primary outcome was pregnancy rate, expressed as an event rate and 95% confidence interval (95% CI). RESULTS:Ten studies with a total of 587 patients were included in the final analyses (Metformin: 5 studies, n = 192; Bariatric surgery (BS): 5 studies (2 Roux-en-Y gastric bypass, 2 sleeve gastrectomy, 1 Roux-en-Y gastric bypass + sleeve gastrectomy), n = 186). The average time to follow-up was 18.25 months (range 3-36) with a shorter time to follow-up in the metformin group compared to the bariatric surgery group (Metformin: 11.2 vs BS: 24.5 months). While metformin increased the likelihood of pregnancy compared to placebo or non-surgical interventions (OR = 3.08, 95% CI 1.29-7.37, p = 0.01), the pregnancy rate after bariatric surgery was greater than metformin (34.9%, 95% CI 0.20-0.53 vs 17.1%, 95% CI 0.12-0.23, p = 0.026 for the difference). Additionally, there was a trend to a greater improvement in menstrual irregularity in the bariatric group compared to the metformin group with a reduction of 92% in the bariatric cohort compared to a reduction of 54% in the metformin cohort, but the data was limited. CONCLUSION/CONCLUSIONS:Bariatric surgery appears to be a more effective treatment strategy for patients with PCOS and class 3 obesity compared to metformin alone. Women with PCOS and infertility should consider bariatric surgery for weight loss and improvement in pregnancy outcomes.
PMID: 33483916
ISSN: 1873-4626
CID: 4767872
Intragastric Balloon Improves Steatohepatitis and Fibrosis [Case Report]
Lin, Elissa; Huang, Xiaoyan; Pei, Zhiheng; Gross, Jonathan; Popov, Violeta
Obesity is a major risk factor for nonalcoholic steatohepatitis (NASH). Although weight loss has been shown to reverse histologic features of NASH, lifestyle intervention alone is often challenging and unfeasible. In this case report, we discuss the effects of intragastric balloon (IGB) therapy on steatosis, fibrosis, and portal pressures. We also demonstrate that improvement in histologic features persist at least 6 months after IGB removal. Although there are little data thus far to support IGB therapy in the treatment of NASH, our case provides evidence of the potential benefit of IGB on improving metabolic parameters and markers of liver fibrosis.
PMCID:7810505
PMID: 33490302
ISSN: 2326-3253
CID: 4766842
Long-term Efficacy of a Multidisciplinary Minimally Invasive Approach to Weight Management Compared to a Single Endoscopic Bariatric Therapy: A Cohort Study [Meeting Abstract]
Young, Sigrid S.; Sidhu, Sharnendra; Aleman, Jose O.; Popov, Violeta
ISI:000717526102254
ISSN: 0002-9270
CID: 5523482
Rate and Burden of Advanced Colorectal Neoplasia in Adults Approaching the Screening Age: An Opportunity to Reduce the Incidence of Early-Onset Colorectal Cancer [Meeting Abstract]
Hussan, H; Akinyeye, S; Porter, K; Stanich, P P; Gray, D; Katona, B; Popov, V; May, F P; Carethers, J
INTRODUCTION: Early-onset colorectal cancer (CRC diagnosed <50 years) is on the rise, making prevention a public health priority. However, debate still exists on whether to initiate CRC screening at age 45 vs. 50. Further, fifty percent of early-onset CRC is diagnosed <45 years of age. We hypothesize a gradual increase in the rate of advanced colorectal neoplasia (i.e., CRC or high-risk polyps) with advancing years of age as opposed to a spike at age 50. We also propose that lack of CRC screening in ages 40-49 underestimates the true burden of advanced neoplasia in that age group.
METHOD(S): We performed a cross-sectional analysis of adults aged 20-60 years who underwent colonoscopies in 2017-2020. All subjects were average-risk for CRC with a complete colonoscopy and adequate bowel preparation. Our primary outcome was the rate and number of detected colorectal neoplasia in 1-year age increments, focusing on the transition between ages 40-44, 45-49, and 50-54 years. We compared advanced neoplasia, high-risk polyps (size $10, villous morphology or highgrade dysplasia), and non-high-risk polyps.
RESULT(S): The cohort included 8,593 adults aged 20-60 (55.9% female and 21.3% racial/ethnic minorities). The majority of adults (n = 5,927 or 68.9%) had a colonoscopy $50, mainly for CRC screening (Figure 1a). Advanced neoplasia rates increased gradually per age-year between 20 and 60 (Figure 1b). Specifically, the mean rate of advanced neoplasia was not statistically different from 40-44 (5.4%) to 45-49 (8.0%) to 50-54 (8.4%), although it was higher in 50-54 vs. 40-44 (Table 1). In contrast, there was a steep increase in detection of advanced neoplasia at age 50. Specifically, the number of adults with newly diagnosed advanced neoplasia increased by 103% from 40-44 to 45-49 and by 340% from 45-49 to 50-54 (Figure 2a). This rise was mainly due to uptake of CRC screening that increased the detection of advanced neoplasia by 67% in ages 45-49 and 467% in 50-54, as opposed to undergoing diagnostic colonoscopies alone (Figure 2b).
CONCLUSION(S): We report slow rise in rates of advanced neoplasia as adults approach age 50. Our data also solidify the impact of CRC screening uptake with a spike in advanced neoplasia burden $50. Combined, these findings supports an opportunity to detect neoplasia earlier, and prevent early-onset CRC, by starting screening at age 45 or 40. Future studies assessing novel, cost-effective, strategies to achieve earlier screening are urgently needed
EMBASE:633656198
ISSN: 1572-0241
CID: 4720622
Is Artificial Intelligence for Colonoscopy Ready for Prime-Time: A Systematic Review and Meta-Analysis of Randomized Controlled Trials [Meeting Abstract]
Satiya, J; Dammeyer, K; Ahmad, O; Stoyanov, D; Lovat, L; Popov, V
INTRODUCTION: Colonoscopy is the best tool for to screen for colorectal cancer. Adenoma detection rate (ADR) is the main quality control indicator for colonoscopy. An improvement in ADR translates into a reduction in the number of index and interval colorectal cancers. Computer-aided polyp detection (CADe) can improve ADR but the impact of real-time CADe on colonoscopy metrics has not been rigorously studied. We aim to conduct a systematic review with meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy of CADe to detect colorectal neoplasia.
METHOD(S): Electronic databases (Pubmed Central, OVID Medline, Embase, EBM Reviews Cochrane Central Register of Controlled Trials) were interrogated from inception until May 2020 for RCTs that compared real-time CADe with standard colonoscopy (E). Data was reviewed separately by two authors. Adult patients undergoing diagnostic and screening colonoscopies were included. Primary outcomes were polyp detection rate (PDR) and ADR. Secondary outcomes were total number of polyps detected, pooled ADR and withdrawal time. A random effects model was used to estimate mean differences (MD), odds ratios (OR) and rate ratios (RR) with 95% confidence intervals (95% CI). Heterogeneity was assessed with I2 statistic, with >50% considered substantial.
RESULT(S): The search yielded 923 results. 6 studies met inclusion criteria. Controls included a sham system and colonoscopies without AI. The total number of subjects included in all studies were 5214. The mean age of patients was 49.49 years, and 47.55 % of the subjects were female. The mean BPPS in the CADe group was 6.7 (95% CI 6.61,6.8), similar to that in the E group. The pooled ADR for colonoscopy with CAD was 33%, and the pooled ADR for colonoscopy alone was 22.8%. Both, ADR and PDR were higher with CADe, OR 1.54 (95% CI 1.23-1.94) and OR 1.49 (95% CI 1.24-1.80), I2 5 0 for both. Number of polyps detected was also higher with CADe, OR 2.42 (95% CI 2.12-2.76), I2 = 0. Withdrawal time was significantly longer (by less than a minute) in the CADe group, MD of 0.74 (95% CI).
CONCLUSION(S): Automatic polyp detection systems resulted in improved polyp and adenoma detection rates, but with increased withdrawal times, compared to standard colonoscopy. CADe use was associated with a significantly higher adenoma detection rate (ADR; 34% vs. 23%). CADe and standard colonoscopies had comparable detection rates of polyps 5-10 mm in size, but CADe had higher ADRs for diminutive polyps, and for polyps greater than 10 mm
EMBASE:633656842
ISSN: 1572-0241
CID: 4718902
The effect of endoscopic bariatric therapies on diabetes outcomes: A systematic review [Meeting Abstract]
Noor, B; Ou, A; Thompson, C C; Popov, V
INTRODUCTION: Endoscopic bariatric therapies (EBTs) have become available for the treatment of obesity, but their role in the treatment of diabetes is not well defined. EBTs can loosely be grouped into gastric or small bowel EBTs, with some data suggesting that small bowel EBTs have greater effect on diabetes. Our aim is to assess the impact of EBTs on diabetes and compare the effect of small bowel EBTs to gastric EBTs on diabetes outcomes, gut hormones, and weight loss parameters.
METHOD(S): MEDLINE, Embase, and Cochrane were searched through 2018. Randomized clinical trials and observational studies of EBTs that reported diabetic outcomes with >5 adult patients with obesity and at least 3 months of follow up were included. Primary outcomes included the pooled mean difference (MD) in baseline and final values in weight loss (% total weight loss, % excess weight loss, BMI change from baseline) and glycemic control (fasting glucose, HbA1c) parameters. Secondary analyses included changes in gut hormones by Hedges' g: ghrelin, glucagon-like peptide 1 (GLP-1), peptide YY (PYY), and glucose-dependent insulinotropic peptide (GIP). Gastric EBTs included intragastric balloons, gastric restrictive procedures such as endoscopic sleeve gastroplasty (ESG), primary obesity surgery endoluminal procedure (POSE), transoral endoscopic vertical gastroplasty (TOGA), aspiration therapy. Small bowel EBTs included duodenal-jejunal bypass liner (DJBL), duodenal mucosal resurfacing (DMR), incisionless intestinal anastomosis system (IAS).
RESULT(S): From 1053 citations, 79 studies with 7,692 subjects were included. EBT use for 3-12 months was associated with significant improvements in diabetes outcomes and weight loss indices compared to baseline or control groups (Table 1). Weight loss outcomes with small bowel EBTs were similar to gastric EBTs. Small bowel EBTs led to a statistically significant greater improvement than gastric EBTs in diabetic parameters. Improvements in diabetes were associated with weight loss for gastric EBTs and an increase in postprandial GLP-1 and PYY for small bowel EBTs (Table 2).
CONCLUSION(S): Discussion: Diabetes and weight loss parameters improved significantly after 3-12 months of EBT. Small bowel EBTs were more effective than gastric EBTs, likely due to different mechanisms of action. EBT should be considered as an option to treat obesity in patients with diabetes in conjunction with diet and lifestyle interventions
EMBASE:633659869
ISSN: 1572-0241
CID: 4720432